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FDA Registration: 3004011380 Year Established: 2005 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: CE Certified
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Inverness Medical Innovations, Inc. manufactures, markets & distributes agents for use in women's health, cardiology and infectious disease. We offer research, development and supply of professional d more...
www.focusdx.com | Phone: +1-(703)-480-2500
FDA Registration: 2023365
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Focus Diagnostics, Inc. develops & markets quality services for rare, unusual and emerging infectious & immunologic diseases. We are an ISO 13485 certified company. We offer products like HerpeSelectr more...
Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.
